AI-driven life sciences transformation

Governance-first AI for regulated life sciences.

Senior-led advisory and software for pharmacovigilance, clinical operations, and regulatory affairs: AI that is auditable by design, governed by experts, and deployed with the rigor your inspectors expect.

Built to the standard of
  • EU AI Act high-risk posture
  • ISO/IEC 42001 AI management
  • 21 CFR Part 11 & Annex 11
  • CIOMS AI in pharmacovigilance

Our thesis

In regulated science, governance is not the brake on AI adoption: it is the enabler.

The conservatism of pharmacovigilance is rational: you have to prove a system before you trust it. We treat that as the design starting point, not an afterthought.

Teams that build audit-ready infrastructure first are the ones that deploy faster, pass inspection, and earn the confidence of health authorities. That is the work we do.

How we work

Three connected phases.

Clients may enter at any point, but the structure holds: understand the opportunity, demonstrate it on our environment, deploy it safely in yours.

01Discover

We map your workflows in their real organizational context, identify where AI can genuinely move the needle, and deliver a prioritized set of use cases with realistic build paths, effort estimates, and a clear definition of success.

How discovery works
02Demo

We build a working system end-to-end on our environment and show you the outcome before your team commits to deployment: develop, test, review, establish, finalize, against your real use case.

See the demo phase
03Deploy

We deploy into your environment with the compliance discipline regulated work demands: GxP and 21 CFR Part 11 alignment, audit-trail and explainability design, PII governance, role-based access, and human-in-the-loop control.

Inside deployment

Flagship product

SDI: Safety Decision Intelligence.

An intelligence layer that sits above your validated safety systems. SDI ingests safety documents and data across sources, performs structured assessment, and produces audit-ready outputs for health-authority requests and signal evaluation, replacing uncontrolled tooling with traceable, reproducible work.

Capabilities

  • Document summarization
  • Signal intelligence & assessment
  • Narrative & case-prep support

What it produces

  • Defensible HA responses
  • Signal summaries
  • Consistent ICSR narratives
21 CFR Part 11 EU AI Act Art. 9 / 13 / 14 ICH E2B(R3) ISO 42001 Immutable audit trail Human-in-the-loop

Explore the use cases

1
IngestICSRs, PSURs, DSURs, literature, HA queries
2
AnalyzeSummarize, synthesize signals, draft narratives
3
ReviewNamed-reviewer, human-in-the-loop sign-off
4
OutputAudit-ready assessments & signal summaries

Track record

Two decades of senior R&D experience, applied to AI in regulated environments.

~50%
Reduction in operational workflow effort
70 → 98%
Audit performance trajectory
20+ yrs
Pharma R&D and technology transformation

Client outcomes

What deployment delivers.

  • Faster insight generation from safety and regulatory documents
  • Earlier signal identification across PV data sources
  • Audit-ready outputs that hold up to inspection
  • Operational efficiency at human-in-the-loop scale
  • Regulatory readiness across jurisdictions and products
  • Expert capacity redirected to expert judgment

Areas of expertise

Where regulatory, technical, and operating knowledge meet.

  • Pharmacovigilance & safety operations
  • Clinical operations & trial conduct
  • Regulatory affairs & submission readiness
  • GxP & 21 CFR Part 11 validation
  • ISO/IEC 42001 AI management systems
  • EU AI Act risk classification
  • Audit trail & explainability design
  • PII handling & data governance
  • Model risk management
  • Human-in-the-loop architecture

Leadership

Senior expertise, hands-on.

A senior-led alternative to large firms and their handoff structures. The advisor who scopes your engagement does the work.

Portrait of Arvind Bellur

Arvind Bellur

Founder & Principal

A career spanning life sciences R&D and technology transformation. Arvind founded Altio Advisory to deliver focused, senior advisory in an industry over-served by junior generalists, grounded in pharmacovigilance operations, clinical platforms, regulatory technology, and AI-enabled operating-model design at global pharma scale.

Portrait of Evren Yucekus-Kissane

Evren Yucekus-Kissane

AI Architect & Researcher

Specializes in machine learning, generative AI, and analytics-platform design, with prior roles at Sanofi and CSL building architectures for scientific use cases. Founded the AI and quantum-computing research program at the University of Maryland; focused on AI/ML system architecture for regulated environments.

More about Altio Advisory

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Every engagement starts with a problem worth solving.

Spend an hour pressure-testing where AI fits in your regulated environment, and what it takes to deploy it to production with full compliance.